Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor Decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation. All endpoint timings refer to the opening of the aortic cross clamp (t=0)
Efficacy of Custodiol-N and its safety is being thoroughly studied in adults undergoing solid organ transplantation. In addition, safety data are available from its use as cardioplegic solution in approximately 400 adults. Paediatric cardiac surgery nearly exclusively addresses congenital heart disease (CHD). CHD comprises a wide variety of congenital malformations of structures of the heart or the great vessels. The causes may be genetic, environmental or both. The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custodiol-N | Experimental | organ will be perfused with Custodiol-N solution |
|
| Custodiol | Active Comparator | organ will be perfused with Custodiol solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heart will be treated with Custodiol-N | Drug | cardioplegia solution will be administered with perfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety assessment | Continuous adverse events (AEs) reporting | AEs up to 30 days postoperatively |
| safety assessment | Myocardial protection in surviving patients assessed by quantification of perioperative CK-MB levels (U/l) | CK-MB (Creatinkinase-MB) levels at baseline until postoperative day 2 and postoperative day 7 or discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Description of hemodynamics | Vital signs (blood pressure (mmHg)) | day 7 postoperatively |
| Description of hemodynamics | Vital signs (heart rate (bpm)) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philippe Grieshaber, PD Dr. | Sektion Kinderherzchirurgie, Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Münster, Germany | Principal Investigator |
| Christine-Elena Kamla, Dr. | Deutsches Herzzentrum München, TUM Universitätsklinikum, Germany | Principal Investigator |
| Mohamed Salem, Dr. | Kinderherzzentrum, Universitätsklinikum Gießen und Marburg GmbH, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Gießen und Marburg GmbH, Abteilung für Kinderherzchirurgie und angeborene Herzfehler | Giessen | 35385 | Germany | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C549285 | Custodiol-N solution |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The patient and their legal representatives will be blinded to treatment. All other parties are unblinded.
| heart will be treated with Custodiol | Drug | cardioplegia solution will be administered with perfusion |
|
| day 7 postoperatively |
| Description of hemodynamics | Vital signs (body temperature (°C)) | day 7 postoperatively |
| Description of hemodynamics | Vasopressor/ Catecholamine/ Vasodilator (incl. Milrinone)/ Levosimendan intake (yes/no by timepoint and amount (μg/kg/min)) | day 7 postoperatively |
| Description of hemodynamics | Nitric oxide ventilation (yes/no by timepoint) | day 7 postoperatively |
| Description of hemodynamics | Extracorporeal membrane oxygenation (ECMO) support (yes/no by timepoint) | day 7 postoperatively |
| Description of hemodynamics | Need for placement of a permanent Medical Circulatory Support (MCS) (left ventricular assist device (LVAD), right ventricular assist device (RVAD), biventricular assist support (BiVAD)), (yes/no by timepoint) | 30 days postoperatively |
| Description of hemodynamics | Need for heart transplant (yes/no by timepoint) | 30 days postoperatively |
| Description of echo | Systemic-ventricular function (good, moderately impaired, severely impaired) | Baseline, after skin closure and day 7 postoperatively |
| Description of cardiac injury | Creatine kinase (CK (U/l)) | at baseline until postoperative day 2 and postoperative day 7 or discharge |
| Description of cardiac injury | Troponin T (ng/ml) | at baseline until postoperative day 2 and postoperative day 7 or discharge |
| Description of hospitals stay/ death | Death (date) | 30 days postoperatively |
| Description of hospitals stay/ death | readmission (to hospital or intensive care), (yes/no and number) | 30 days postoperatively |
| Description of hospitals stay/ death | Length of ICU stay (start and end date) | 30 days postoperatively |
| Description of hospitals stay/ death | Length of hospital stay (start and end date) | 30 days postoperatively |
| Description of surgery | Aortic cross clamping time (min) | during surgery |
| Description of surgery | Incision-to-closure-time (min) | during surgery |
| Description of surgery | Reperfusion time (min) | during surgery |
| Description of surgery | Number of intraoperative administrations of cardioplegia | during surgery |
| Description of surgery | Total administration duration (min) | during surgery |
| Description of surgery | Total administration amount (ml) | during surgery |
| Description of 12-Lead-ECG | Shift in 12-Lead-ECG (ECG QT Interval) | baseline and day 1 postoperatively (Intensive Care Unit) |
| Description of cardiac arrhythmias | Current heart rhythm (Sinus rhythm, atrioventricular block (AV-Block °I), AV-Block °II, AV-Block °III, Ectopic atrial rhythm with intact AV conduction, other tachycardiac arrhythmia) | until day 7 postoperatively |
| Description of cardiac arrhythmias | Tachyarrhythmic event since last visit (JET/atrial fibrillation/atrial flutter/ ventricular arrhythmia) | until day 7 postoperatively |
| Description of cardiac arrhythmias | Need for antiarrhythmic therapy other than beta blockers after end of aortic cross-clamping since last visit (e.g. Adenosine, Amiodarone, Flecainid), (yes/no) | until day 7 postoperatively |
| Description of cardiac arrhythmias | Current cardiac pacing (none/atrial/ventricular/sequential) | 30 days postoperatively |
| Deutsches Herzzentrum München, TUM Universitätsklinikum, Klinik für Chirurgie angeborener Herzfehler und Kinderherzchirurgie |
| München |
| 80636 |
| Germany |
| Universitätsklinikum Münster, Klinik für Herz- und Thoraxchirurgie,Sektion Kinderherzchirurgie | Münster | 48149 | Germany |